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An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+ (ADXS11-001)

This study has been terminated.
(Study stopped due to lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Advaxis, Inc.
ClinicalTrials.gov Identifier:
NCT01116245
First received: April 20, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Biological: ADXS11-001 (Lm-LLO-E7)
Drug: Placebo Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single Blind, Placebo Controlled Phase 2 Study to Assess the Safety of ADXS11-001 for the Treatment of Cervical Intraepithelial Neoplasia Grade 2/3

Resource links provided by NLM:


Further study details as provided by Advaxis, Inc.:

Primary Outcome Measures:
  • The primary end point will be a histologic determination of whether CIN 2/3 present at entry had regressed. [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary efficacy endpoints include whether HPV DNA was reduced or eliminated and a comparison of their excised cervical tissue controls to assess the extent of disease in treated vs. untreated patients. [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose
5x10^7 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Biological: ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Experimental: Middle Dose
3.3x10^8 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Biological: ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Experimental: High Dose
1x10^9 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Biological: ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Placebo Comparator: Placebo
normal saline x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Drug: Placebo Control
3 intravenous infusions of normal saline at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.

Detailed Description:

Worldwide, many women carry HPV and cervical cancer is the leading cancer killer of women under the age of 50. Although its consequences are considerably less severe in the US, it leads to considerable morbidity. Many published clinical trials describe the immunotherapeutic treatment of early stage, pre-invasive, cervical cancer. It is widely recognized that immunotherapies are most effective in early stage disease because the immune system is least debilitated and disease burden is lowest. Invasive cervical cancer is preceded by a long, slowly progressive, pre-invasive phase termed Cervical Intraepithelial Neoplasia (CIN), which allows for this therapeutic approach. An ideal therapy would result in the remission of CIN 2/3 without damage to cervical tissue. A National Institute of Cancer panel charged with achieving consensus on this issue concluded that a non-surgical medical treatment for this indication would be valuable

The primary objectives of this trial are to test three doses of Lovaxin C to determine if vaccination with Lovaxin C in women with CIN 2/3 for whom surgery is indicated can safely reverse the disease compared to placebo treated control patients.

An earlier Phase 1/2 trial of Lovaxin-C in late stage metastatic cervical cancer used a regimen of two doses given with a 28-day interval. That regimen was shown to be safe and to generate reduction in tumor burdens in some patients. In this trial we will treat earlier stage disease in healthier patients with better immune systems, will use the same and lower doses as given before, but add an additional dosing to the regimen by administering the lowest dose that we assessed previously and by adding a third vaccination to the prior regimen. Unlike the phase 1 trial in which 2 doses were given with a 3 week separation, dosing in the proposed trial will be separated by 4-week intervals.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed CIN 2/3 that requires surgical intervention

Exclusion Criteria:

  • Previous history of listeriosis
  • Steroid use
  • Antibiotic use
  • Negative anergy panel
  • HIV positive
  • Pregnant or actively trying during the treatment period
  • Intercurrent disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116245

Locations
United States, Arizona
New Horizons Women's Care, LLC
Chandler, Arizona, United States, 85224
Arizona OB/GYN Affiliates, PC
Phoenix, Arizona, United States, 85016
Precision Trials
Phoenix, Arizona, United States, 85032
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, California
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
Altus Research
Lake Worth, Florida, United States, 33461
United States, Illinois
Center for Women
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Dept. of OB/GYN Oncology
Indianapolis, Indiana, United States, 46202
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
New York Downtown Hospital
New York, New York, United States, 10038
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
InVisions Consultants, LLC
San Antonio, Texas, United States, 78217
InVisions Consultants, LLC- c/o Institute for Women's Health
San Antonio, Texas, United States, 78212
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Advaxis, Inc.
Investigators
Study Director: Robert Petit, PhD Advaxis, Inc.
  More Information

No publications provided

Responsible Party: Advaxis, Inc.
ClinicalTrials.gov Identifier: NCT01116245     History of Changes
Other Study ID Numbers: Lm-LLO-E7-07
Study First Received: April 20, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Advaxis, Inc.:
Cervical Intraepithelial Neoplasia Stage 2/3

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 24, 2014